Clinical Research Associate Job at Alliance Foundation Trials, LLC in Boston

Alliance Foundation Trials, LLC (AFT) is a wholly-owned subsidiary of the Alliance for Clinical Trials in Oncology Foundation, created to enhance and expand cancer clinical research. AFT conducts large-scale clinical trials to address medical care and treatment questions, collaborating with industry partners to discover improved ways to prevent, treat, and cure various cancers, including leukemia, lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal tract.

About the role

The Clinical Research Associate (CRA) supports the management and execution of clinical trial operations across AFT studies. This role focuses on site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA collaborates with CROs, vendors, and investigative sites to ensure compliance with ICH GCP guidelines and organizational standards, supporting studies from start-up through ongoing maintenance.

Responsibilities

• Assist the operations team in supporting Alliance member sites and elevate site-related issues as necessary.
• Send, track, and review study-specific and global feasibility questionnaires.
• Assist with site selection and recruitment by generating site identification reports (e.g., site accrual), collecting, reviewing, and tracking site feasibility/credentialing documentation, and following up on site accruals.
• Track training information and issue trainings for sites and contacts.
• Collect essential documents related to study start-up and review IP release packages.
• Prepare for and execute Investigator meetings and other site training programs.
• Assist with the creation of start-up plans and templates.
• Ensure proper and timely filing of all relevant study documents into the eTMF to maintain compliance with work instructions, SOPs, ICH GCP guidelines, and AFT expectations.
• Perform routine reviews of filing procedures to ensure adherence to current quality guidelines.
• Accurately enter and manage data within the Clinical Trial Management System (CTMS), including tracking completed training information, maintaining site information and rosters, reviewing monitoring reports for deficiencies, assessing issue escalation and resolution, and providing feedback to CRO contacts.
• Participate in co-monitoring activities.
• Communicate with CROs, vendors, and/or study sites to support studies, including monitoring study-related email accounts.
• Conduct regulatory review of ICF changes and coordinate review by the Executive Officer and contracts team.
• Coordinate study-related meetings, take detailed minutes on decisions and action items, and distribute them to the team as assigned.
• Perform other related duties to meet departmental and company objectives.

Requirements

• A minimum of a BA/BS degree is required; a degree in a health or science major is preferred.
• 2–4 years of relevant experience in biotech, pharma, and/or CRO, including at least 1 year of clinical research industry experience.
• Working knowledge of clinical monitoring responsibilities and procedures.
• Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
• Proficient in Microsoft Office Suite, especially Word and Excel.

Skills

• Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic environment.
• Strong interpersonal, written, and verbal communication skills.
• Flexible and adaptable to a small business workplace environment.

Benefits

• 8 weeks of paid time off (including PTO, sick, and holidays) during the first year.
• Medical, dental, and vision plans with a 100% employer-paid option for employees.
• Tuition reimbursement stipends.
• Continuing education opportunities.
• 3% employer match for retirement investments.
• Annual Employee Performance Bonus Program.
• Annual Cost of Living Adjustment.
• 50% commuter reimbursement.
• Healthy work/life balance and flexibility.

This is a contract position based in Boston, MA.